VNS Therapy (Vagus Nerve Stimulation)

http://www.vnstherapy.wordpress.com

Friday, September 6, 2013

My continuing pleas and appeals to Jonathan Blum – CMS and Madam Secretary Kathleen Sebelius

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, September 05, 2013 4:30 PM
To: Jonathan Blum, Deputy Administrator Director - CMS
Cc: Madam Secretary Kathleen Sebelius
Subject: A continuing please for a favorable "Compassionate use" decision for the already implanted VNS depression patients...

Dear Mr. Blum

Not being a religious person although it is an auspicious time of year for some, I would like to wish you and your family and all those reading my correspondence, L’Shanah Tovah.

I can’t help but to continue reflecting back upon your statement to me that “Patient perspectives are invaluable to our review process” with much agitation.

Now that I’ve had some time to calm down I wanted you to know the statement had infuriated me at the time. Just as I acknowledge that you’re not an M.D. and in all likelihood your “medical team” has little to no experience in tending to psychiatric patients or this implanted patient population I wanted you to know that I am not a patient but a support person and caregiver. Nor am I just any ordinary support person and caregiver.

In fact, I am an expert. I am an expert far more knowledgeable than any of your medical team reviewing this issue for “Compassionate use” as it relates to my spouse Joyce and for all these implanted VNS patients for depression. I am an expert far more knowledgeable than any of the physicians who have attended to my spouse all these years. Now that you’ve finished scratching your head and wondering whether I’m a kook or something else I’ll elaborate.

I am an expert to my spouse Joyce as it relates to her major depressive illness. There is absolutely no one who knows more about my spouse, her illness, her medications, her treatments, her responses, her side-effects and what has and has not worked for her all these years. There is no one who has kept more detailed records and has observed her reactions 24/7/365 than I.

Neither you nor your medical team has carefully and astutely observed and maintained empirical data as I have through 50 years of marriage. So when you speak of “perspectives” it grinded upon me. You may have perspectives but when it applies to my spouse Joyce I have careful observations, empirical data and record keeping and detailed facts.

You folks have no knowledge of her responses, efficacy or reactions to her Zoloft (sertraline HCl), Lamictal (Lamotrigine) or for that matter the pharmacopeia of drugs she’s trialed over decades. You folks have no knowledge of her responses, efficacy or reactions to ECT (Electroconvulsive shock therapy) trials over decades, do you? Your department and staff quite honestly and frankly don’t know “shit from Shinola” as to what has and has not worked for my spouse and yet you talk about perspectives and reviews.

We have been fortunate through these years to have very knowledgeable, capable and compassionate physicians attend to Joyce. And in doing so we retained those who also had the ability to listen attentively to what we know and thought. Those who exhibited the deity syndrome were quickly dismissed.

I responded twice to CMS during the comment period for VNS Therapy for depression. I was reminded by someone from CMS that the information I supplied was anecdotal. If that be the case while my knowledge and information may be considered anecdotal then as an expert tending to my spouse all that your medical review board, in my opinion, could possibly offer up is valueless information or perspectives as they truly no nothing about my spouse.

I am also reminded about the Chinese physician, a number of years ago, who attended to cancer patients in the hinterlands of his country. Through listening to patients and then through careful observations and detailed record keeping he was able to achieve remarkable success rates using arsenic for his cancer patients. That Chinese physician faced ridicule and scoffing on the part of Western physicians just as I’ve similarly have read (i.e. Peter Laurie formerly of Public Citizens and I believe now with the FDA) as it pertains to VNS Therapy for depression. The point being; the Chinese physician as I later read was eventually awarded a Noble prize for his observations, findings and newer effective treatment. I am not a physician but I find I am facing similar circumstances in dealing with HHS and CMS.

What does this all have to do with Joyce? You can’t close your eyes or shut your ears to what you are reading and being told. I am telling you as her expert support person that after 50 years of my observations and record keeping that VNS Therapy has worked favorably for my spouse like no other therapy with absolutely no side-effects or safety issues. Not only is she a responder she is in remission for almost 14 years. I know with certainty there are other attending psychiatrists who can attest to similar observations and findings with their patients. As an expert to my spouse how in good conscience can you or Madam Secretary Sebelius continue to delay issuing a favorable “Compassionate use” decision to all the patients similarly responding to that of Joyce and wishing to continue with the therapy? How can you both in good conscience allow anyone to be implanted with a foreign object and simply turn your backs and walk away from their care?

This doesn’t require a medical team to review. This is a matter of medical ethics, morals and humanism and doing what is right and just. I’ll also add in the long-run money will be saved.

If a physician inadvertently during surgery left an instrument or object in a patient he or she might face charges for negligence. Don’t you think that your department has intentionally committed the very same or similar negligence? Your department through its oversight or ignorance or lack of concern has since May 4, 2007 not addressed this serious medical negligence.

Today I received an email petition for an individual appealing and seeking to obtain a trial medication for a cancer drug. While I can empathize with the individual doing all one can to maintain hope and life I am again pointing out to you we are not talking about a trial and an uncertain outcome in our pleas. 100% of the implanted patients wanting to continue with this therapy are responders and obtaining efficacy. I shall also point out to you again; these patients are responding for multiple years a fact which in and of itself is truly remarkable and won’t show up in your medical teams review statistics. I’ll also point out to you these individuals are willing to undergo continued surgeries to maintain their wellness another fact that won’t show up before your medical review team.

At this point in time, knowing that which I do, isn’t it time that both you and Madam Secretary Sebelius acknowledge the oversight and correct this egregious negligence and injustice? More importantly wouldn’t it suit you both better to know and allow these patients to enjoy the sweet nectar of their wellness rather than condemning them back to Hell?

Something else I’d like to share with you that does not show up in any of your data or statistics. I am truly not an arrogant, pretentious or mean spirited individual. In fact I was brought up to respectful and caring of others while at the same time I am assertive and most importantly, persistent. Above my desk hangs a note with several precepts by which I try to live my life and which I’d like to share with you.

The first and most important of which that has served me well is:

“Persistence”

“Nothing in this world can take the place of persistence.

Talent will not; nothing is more common than unsuccessful people with talent.

Genius will not; unrewarded genius is almost a proverb…” – Calvin Coolidge

“Happiness isn’t what you have…

It’s the ability to enjoy

What you have!” – Author unknown

“What we have done for

ourselves alone dies with us;

what we have done for

others and the world remains

and is immortal” – Albert Pike

“This is my simple religion. There is no

need for temples; no need for

complicated philosophy. Our own brain

our own heart is our temple; the

philosophy is kindness.” – Dalai Lama

Once again, I ask, I plead for you or Madam Secretary Sebelius to please pen your signature to a favorable “Compassionate use” document for the VNS implanted patients wanting to continue the therapy for depression.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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Tuesday, September 3, 2013

I met with Congresswoman Debbie Wasserman Schultz and her Senior Congressional Aide

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, August 30, 2013 3:35 AM
To: Vivian F. Piereschi, Senior Congressional Aide to Congresswoman Debbie Wasserman Schultz

Subject: VNS (Vagus Nerve Stimulation) - Request for favorable "Compassionate use" decision...

Dear Vivian,

It was very nice meeting you yesterday at the YMCA and for taking the time to chat with me. I’m only sorry I didn’t remember Rene Smoley encouraging me earlier on to contact you. Anyway, I did finally meet you and gave you my letter of advocacy for which I thank you. I briefly spoke to Debbie and I told her I gave you the initial information.

We are in urgent need of Debbie’s advocacy in obtaining for us a favorable “Compassionate use” decision from either Madam Secretary Kathleen Sebelius or from Jonathan Blum at CMS.

I am not only an advocate for my spouse Joyce but also for a small group of former volunteer medical study subjects and patients already implanted with a VNS (Vagus Nerve Stimulator) for depression. These patients are all benefiting from the therapy and saving our government substantial sums of money as they are no longer suffering severe depression and have far less medical needs and expenses as they once did suffering decades of major depression. This therapy was FDA approved but subsequently denied by CMS. Yet the very same therapy is CMS approved for the epilepsy indication.

One statistic I am trying to impress upon these bureaucrats is that 100% of this group is finally responding to a therapy and maintaining efficacy over unprecedented time period which is unheard of by way of psychiatric therapies.

Joyce’s pulse generator containing the battery is soon to expire. She is on her second pulse generator approaching 9 years. The two previous pulse generators were implanted and covered under the research study program. Once the FDA approved the depression indication the sponsor was no longer responsible and for the first time ever a medical device FDA approved was declined by CMS leaving all the study subjects and those implanted after the FDA approval out in the cold in a Catch-22. No one will take responsibility for health insurance coverage for replacement, care and/or ex-plantation.

Here is the link to my website containing much of my correspondence to HHS and CMS as well as the sponsor Cyberonics, Inc. as well as the background for this egregious and morally reprehensible oversight upon the part of the sponsor, FDA, all the medical professionals who designed the study and created this loophole as well as CMS ineptitude or lack of concern to grandfather care for the study subjects and patients who obtained the therapy before the formal denial from CMS.

Here is my link to the petition I originally started which should give both you and Debbie a better understanding of our plight. That petition has grown to now encompass all the existing implanted depression patients who are doing well and wish to continue the therapy. My guesstimate is about 300 to 500 depression patients.

From a humanitarian standpoint I’ve culled out a couple of patient emails that I was allowed to share publicly and have copied and pasted the contents below. These patient statements stand very well on their own and are the reasons we are desperate and asking for your help.

Vivian, I am at this advocacy full time, both day and night with little sleep. We are desperate and dread the thought that Joyce wakes up one of these mornings and enters back into the despair that she’s last known about 13 years ago.

Please help us. I am available to discuss and share information at any time.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

From: Kimberly Meek [mailto:k.meek@me.com]
Sent: Wednesday, August 28, 2013 3:58 PM
To: Joyce and Herbert Stein
Subject: Re: VNS Therapy -- D-02 study subject

Dear Herb,

Thanks for the info about the Joyce's replacement pulse generator. I knew that you would know!

You are welcome to share the following publicly…

---

Dear Herb,

Thank you for your hard work and continued support over the years. I have been doing so well that I haven't really kept up with the "goings-on" in the community, which I have been reminded that I should have been doing -- as I am one of those who will most likely be in the catch-22 situation. I was a study participant in the D-02 study.

I can't remember exactly what year I was implanted -- possibly 2005 or 2006. My battery is still functional, but earlier this summer my neurologist/psychiatrist did mention that my battery will wear out in a few years. I haven't asked my current insurance company if they will pay for the surgery, but I seriously doubt they will. My previous insurance company refused to pay for the implant, but I was fortunate enough to be accepted into the D-02 study. It was my last sliver of hope.

It took me about two years to become totally stable after the VNS implant, but I have been stable since then -- at least 7 years (depending upon when I was actually implanted -- I'm not sure what year it was). This is the longest symptom-free period I have had in more than 20 years. No hospitalizations, no ECT, no disability. I'm only on medications and see my psychiatrist every 3 months for med checks. I am a happy and productive (and tax paying!) member of society now. No other medical treatment has worked as well; as long; or with no side effects, as the VNS.

I hope to be able to continue the VNS treatment and have already started saving money for it. I seriously doubt I will be able to save for the full cost of the pulse generator, surgeon and hospital fees, but I'm prepared to take out a home equity loan if necessary. That is how important my VNS is to me. I will risk my home to try to pay for it. And if in a few years I don't have enough saved -- or am not in a good-enough financial situation to obtain a home equity loan -- well, it will be back to expensive hospitalizations, ECT treatments, which often lead to my being disabled. I don't understand why any health insurance company or the US government would be so short-sighted. I also don't understand why Cyberonics (besides corporate greed) would go back on their promise to take care of its study subjects in this situation. As my grandmother would say, "Tacky." Very tacky, indeed.

I don't regret being in the Cyberonics D-02 study. I have been very, very blessed to have had 7 years of being pretty much depression-free thanks to the VNS. I just regret that I'm going to be in a catch-22 situation when my pulse generator battery runs out.

The clock is ticking. I hope someone can do something.

All the best,

Kim

From: KC [mailto:kcsparow@kc.rr.com]
Sent: Wednesday, August 28, 2013 1:34 PM
To: Joyce and Herbert Stein
Subject: Re: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Herb,
I have an estimated three years left before I need a replacement, so my case is not nearly as dire as yours. However, I'm facing the same problem.
Regarding the 2nd group on your list....
> Then there are those patients who obtained or fought to obtain the therapy during the window of opportunity between the FDA approval and CMS national decision to decline.
There is a subgroup of patients in that category, and I am a member.
My surgery was approved during that period. I got the implant, and then I was notified that Medicare had decided not to pay for the surgery or the implant, on grounds that it was "unnecessary" in my case. My surgeon was never paid, and for all I know, neither was Cyberonics.
Consequently, Medicare replied to my most recent correspondence by telling me that since Medicare didn't pay for the implant in the first place, it's not obligated to pay for a new battery when the time comes.
I don't know how many implant patients are in my little subgroup, but the distinction is an important one. Will it dilute your efforts if you include us, as well?
Regards,
Kathleen Cruden
(Kat C. in the Yahoo group)

-----Original Message-----
From: KC [mailto:kcsparow@kc.rr.com]
Sent: Tuesday, August 27, 2013 9:39 AM
To: Joyce and Herbert Stein
Subject: VNS therapy

Dear Herb,

Below is a copy of the letter I sent to Craig Malislow.

It's the most succinct summary of my VNS therapy's success that I've been able to write.

Please feel free to send it to anyone who might listen to our story.

Kathleen

-------------------------------------

I was not a member of the study Joyce Stein participated in, but my

quality of life depends on a VNS implant, and the replacement battery

will not be covered by Medicare.

The device changed my life. I have been bipolar since childhood, and by

the 1990s the depressive part of my cycle extended as long as two years.

The effect on my life was devastating to the point where I was legally

disabled (in 1993), and no medication worked for any length of time. By

2006, I ran out of pharmaceutical options, so my doctor prescribed the

implant. We thought it was covered by Medicare, but shortly after the

surgery, I received a letter from Medicare stating that the implant was

unnecessary, and that my surgeon would not be paid.

The implant became fully effective in about two years, as promised by

Cyberonics. Since late 2008, I have been symptom-free. Anyone who

suffers from a lifetime of chronic depression will tell you that the

subject is never far from your mind, and yet, these days, I even forget

to tell people I'm bipolar. Almost the only time I think about it is

when I try to figure out how to replace the battery. I am finally

digging my way out of two decades of disorganized, disrupted thinking, I

have friends that I can enjoy, my writing is about many topics instead

of limited to my depression.... Life is very good right now, and for the

first time in my life.

I can say those things in all honesty, in spite of the fact that I am

still suffering from fibromyalgia. My life is that good.

My worst fear is that in three years, my battery is going to die and I

will have to return to those dark days. I have begun approaching my

senators' offices, looking for help in changing Medicare's policy. The

first round of contact with Medicare netted me a letter that confused

VNS implant therapy with stem cell research. It's going to be an uphill

battle.

Much depends on Herb and Joyce Stein's ability to get Medicare coverage

for Joyce's implant.

I'm grateful for your interest in their story. If you want to talk to me

about my experience with VNS therapy, please feel free to respond to

this e-mail or call me at the number below.

Sincerely,

Kathleen Cruden

518 Maier Dr.

Belton, MO 64012

816-719-4508

P.S.: There are three additional details that might interest you.

1) I am currently the only VNS patient at Pathways Community Health,

Raymore, MO. Elaine Boyd, who manages my device, is one of several

professionals who have told me that they have other patients who would

benefit from VNS therapy but can't get coverage for the implant.

2) Within four months of the implant surgery, I had to begin weaning

myself off the gabapentin and lithium that I'd been taking for years.

The reason? The implant had begun to compensate so well for

pharmaceutical meds that I was beginning to experience symptoms of

over-medication. I can't remember the cost-savings to Medicare D, but it

seems to me it was in the vicinity of $500 a month. Or $900. Gabapentin

is pretty expensive.

More recently, I had to stop taking Provigil. I had been taking it since

2009, originally for ADD symptoms, and later because I have sleep apnea

and needed help staying alert during the day. But early last year, the

Provigil became too effective, and I had to request that I be weaned off

it as well. My dose went from 400mg daily to a suggested 50 - 200mg a

day as needed, but I seldom take even that small dose.

The cost savings to Medicare D is $1200 a month.

3) I don't know how many implant recipients are now fully employable.

But I do know that if I wasn't dealing with the fatigue and cognitive

problems associated with fibromyalgia, I could be a tax-paying citizen

again. As it is, I am able to be productive in my home at a rate that

was formerly out of the question.

I owe a lot to VNS therapy, and so does Medicare.

From: Amy <keyanote@gmail.com>
Date: August 27, 2013 1:43:55 AM EDT
To: "craig.malisow@houstonpress.com" <craig.malisow@houstonpress.com>
Subject: Cyberonics Vagus Nerve Stimulator for treatment resistant depression

Craig,
I understand you may be interested in stories from people who have a vagus nerve stimulator for treatment resistant depression and now that Medicare will not cover the cost we are out of luck with the only treatment that ever worked for us.
I am so frustrated and feel myself falling back into the "black hole" Herb spoke of in his letter further and further everyday. In March of 2013 I had my battery replaced. It was a $34,000.00 surgery. I was fortunate to have a very caring surgeon that lead me to the hospitals financial department where they had grants that covered all but $550.00 of the surgery. In June I started feeling depressed and then had some odd symptoms with the stimulator and have found out that it is not working properly so it had to be shut off. There could be something wrong with one of the lead wires or there may be scar tissue formed around the wires. They cannot tell by the xray. My surgeon is a general surgeon and for complications with the device has to refer me to a neuro surgeon.
Medicare will not pay to find out or for the surgery to fix it. So now I just have to live without it. The $34,000.00 that was gifted to me in March was wasted.
I don't understand why the one thing that helped me cannot be covered. I have attempted suicide multiple times. I have been on almost every depression medication out there. I have done Ect therapy. Nothing helped me like the Vagus Nerve Stimulator.
I don't know what my future is going to be like now. I can't imagine going back to the life I used to live but I am slipping back and there in nothing that can be done.
Sincerely,
Amy Lasko

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NOTICE OF CONFIDENTIALITY / Disclaimer

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From: Piereschi, Vivian [mailto:Vivian.Piereschi@mail.house.gov]
Sent: Tuesday, September 03, 2013 10:53 AM
To: 'Joyce and Herbert Stein'
Subject: RE: VNS (Vagus Nerve Stimulation) - Request for favorable "Compassionate use" decision...

Hi Herb,

Thank you for the information regarding Vagus Nerve Stimulation. I have forwarded your inquiry to the Centers for Medicare and Medicaid Services. I will be back in touch once I receive a reply from the agency.

Best regards,

Vivian Piereschi

Senior Congressional Aide

Office of Congresswoman Debbie Wasserman Schultz

10100 Pines Blvd.

Pembroke Pines, Florida 33026

(954) 437-3936

(954) 437-4776 fax

Please note: In order to better serve you, our scheduling process has changed. Please submit all scheduling requests online at: http://wassermanschultz.house.gov/scheduling

Wednesday, August 28, 2013

“Compassionate use” decision for VNS for those patients already implanted for depression is near…

I have been informed we are close to obtaining a decision on our pleas for a “Compassionate use” decision for VNS for those patients already implanted for depression.

I have copied and pasted below my recent correspondence with government officials and patients. Please read the documents starting from the bottom up by date so that one will have a chronological order of events and a better understanding of what has transpired.

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, August 28, 2013 5:16 PM
To: 'Turner, Courtney (CMS/OPE)'
Cc: Madam Secretary Kathleen Sebelius; Jonathan Blum; Marilyn Tavenner; Daniel Schreiner; Lynda Gyles
Subject: RE: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Courtney,

I apologize for inundating you with additional information and our pleas for help. It is just so important that these decision makers have a complete understanding of the problems they’ve caused but even more importantly to understand the good they could impart with a favorable “Compassionate use” decision for all the patients already implanted for VNS for Depression wanting to continue the therapy. I sense that some of these medical decision makers, to use an old analogy, are grasping the tail-end of an elephant and concluding they have a mouse and are totally missing the bigger picture.

Despite whatever data they may have had in hand to previously render their decisions they now have a small group of patients that are 100% benefiting from the therapy and wish to continue while at the same time maintaining their wellness over extended years. This apparent insignificant or easily overlooked fact is monumental when one considers the decades of numerous failed short acting drug and other therapies costing the government trillions of dollars over decades in an attempt at achieving wellness for these people. How some of these drugs were ever approved by FDA and CMS in the first place is for another discussion at another time. But it also illustrates the fallibility and poor decision making of these medical review teams when test data is messaged, omitted and results ghost written. There is no such process taking place with the patients I am advocating for. They wish to continue their therapy because they are all benefiting and saving the government money.

I have copied and pasted two (2) additional correspondence (dated August 28, 2013 3:58 PM and 1:34 PM listed below) that I’ve received to justify our impassioned request for a favorable “Compassionate use” decision for all those VNS patients already implanted for depression wishing to continue with the therapy.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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NOTICE OF CONFIDENTIALITY / Disclaimer

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From: Kimberly Meek [mailto:k.meek@me.com]
Sent: Wednesday, August 28, 2013 3:58 PM
To: Joyce and Herbert Stein
Subject: Re: VNS Therapy -- D-02 study subject

Dear Herb,

Thanks for the info about the Joyce's replacement pulse generator. I knew that you would know!

You are welcome to share the following publicly…

---

Dear Herb,

The clock is ticking. I hope someone can do something.

All the best,

Kim

From: Turner, Courtney (CMS/OPE) [mailto:Courtney.Turner@cms.hhs.gov]
Sent: Wednesday, August 28, 2013 2:09 PM
To: Joyce and Herbert Stein
Cc: Schreiner, Daniel (CMS/OPE)
Subject: RE: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

You’re welcome.

CST

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, August 28, 2013 11:42 AM
To: Turner, Courtney (CMS/OPE)
Cc: Sebelius, Kathleen (HHS/OS); Blum, Jonathan D. (CMS/CM); Tavenner, Marilyn (CMS/OA); Schreiner, Daniel (CMS/OPE); Gyles, Lynda (HHS/IOS)
Subject: RE: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Courtney,

I can’t thank you enough for coming to our assistance and for directing my various emails containing our pleas to the proper parties within the government. Hopefully these people can fully comprehend our dire needs and the egregious and moral oversight that has taken place in not caring for this small group of patients.

We seek a favorable “Compassionate use” determination.

I am also sharing this correspondence by way of blind copies to a number of patients, physicians, etc. with whom I’ve collaborated with through the years to keep all updated.

What I’ve not included in my previous pleas is a guesstimate on my part as to the number of patients caught up in this Catch-22 situation.

There really are three (3) groups here although two (2) from my viewpoint are the major ones I’m advocating for at this moment:

1- The first group are the study subjects covered by Cyberonics “Lifetime Reimbursement Guarantee”. This encompasses D-01 study subjects (60 patients), D-02 study subjects (235 patients) and D-20 (which I believe was disbanded and there were no implants). Of the 235 patients in the D-02 I believe 13 dropped out of the study before implantation. So we are discussing approximately 282 study subjects. Of that group I estimate that maybe 40% (about 113 study subjects) are choosing retention of the therapy.

2- Then there are those patients who obtained or fought to obtain the therapy during the window of opportunity between the FDA approval and CMS national decision to decline. At one point Cyberonics was issuing weekly numbers of those who did obtain the therapy that way. When my website was hacked I lost the information that I had copied and posted but I would estimate at the most there may have been about 500 patients that Medicare/Medicaid or private health insurance paid for their implantations. I strongly believe Cyberonics should have a record of those patients as they had staff assisting the prospective patients at that time. Using the same 40% retention rate (about 200 patients) is my rough estimate from that group who wish to retain the therapy. The study subjects, totaling about 113 and the other patient group totaling about 200 I would guesstimate about 313 patients in total are the individuals I’m advocating for who are desperately opting for retention. That’s it, about 313 individuals is my guesstimate who are benefiting from the VNS Therapy and who wish to continue with the treatment and be covered by their medical insurance carriers.

3- Lastly, I am also advocating to never allow a similar fiasco (Catch-22) to happen to any volunteer medical study subjects again and to write in on all volunteer medical study contracts that the responsibility of medical care for the study subjects will remain the responsibility of the sponsor until such time as CMS formally determines acceptability of the treatment which from my understanding would simply mean that Medicare/Medicaid and the private health insurance carriers will then reimburse for treatment. Please correct me if I am wrong in my thoughts on this subject.

I am also led to believe that some of your review folks are more the bureaucrats and number crunchers so I’d also like to throw out to them et al. that we are speaking about a group of patients that are obtaining 100% response and efficacy from their VNS Therapy. I’ll repeat, 100% percent response and efficacy. I’ll defy anyone within the medical community to come up with anywhere near a response rate for any psychiatric therapy coming close to that number. Once again, I’ll also remind the number crunchers these are patients who have suffered for decades and have often been referred to as “the worst of the worst” and have cost our health care system untold millions of dollars and through the use of their VNS Therapy have cut those cuts drastically.

I would also like to apologize to Madam Secretary Sebelius as it was brought to my attention that I was improperly addressing her in my correspondence and that she should be properly addressed as Madam Secretary; so noted

I await nervously and with much anxiety for the formal response which you indicated would be forthcoming shortly.

Once again, I am much appreciative for your personal assistance and for me to have the opportunity to speak to a real live person.

Thank you.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733